Reported Jul 18, 2018 · Terminated
Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with…
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
- Percepta Quad CRT-P MRI SureScan
- REF W4TR04 Product UsageThe CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. These devices are indicated for heart failure patients who may have atrial arrhythmias or AV block
- Lot codes and dates
- GTIN/UPN(a) 00643169735705
- Serial Numbers
2,713 of 2,713 codes
RNV601570SRNV601571SRNV601972SRNV603768SRNV603769SRNV603802SRNV602113SRNV603803SRNV603804SRNV603805SRNV603806SRNV603807SRNV603809SRNV603813SRNV603815SRNV603821SRNV603822SRNV603830SRNV603831SRNV603850SRNV603877SRNV603879SRNV603458SRNV603260SRNV603476SRNV603477SRNV603209SRNV603032SRNV602351SRNV603137SRNV603231SRNV603232SRNV602932SRNV602933SRNV602934SRNV602950SRNV602952SRNV602953SRNV602956SRNV602958SRNV602960SRNV602966SRNV602974SRNV602975SRNV602977SRNV603843SRNV603845SRNV601392SRNV601414SRNV601558SRNV601561SRNV601562SRNV601563SRNV601564SRNV601565SRNV601566SRNV601567SRNV601568SRNV601569SRNV601572S
- Amount recalled
- 3560 units
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
- Nationwide
Why it was recalled
Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the EffectivCRT Diagnostic and the Ventricular Safety Pacing feature (VSP).
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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